The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac Polyaxial Spinal Fixation System.
Device ID | K100685 |
510k Number | K100685 |
Device Name: | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
Contact | Cheryl Allen |
Correspondent | Cheryl Allen ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
Product Code | KWP |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-10 |
Decision Date | 2010-06-18 |
Summary: | summary |